by Ed Susman Contributing Writer, MedPage Today

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Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

DALLAS -- Infusing fibrinolytic agents to myocardial infarction patients before transfer to a center where percutaneous coronary interventions (PCI) can be performed does not appear to offer patients an outcome advantage, researchers said here.

In the one-year results from the STREAM trial, overall mortality was 6.7% among those who underwent the pharmaco-invasive strategy and 5.9% in the patients who underwent primary PCI (P=0.52), reported Peter Sinneave, MD, of the University of Leuven, Belgium.

In a late-breaker presentation at the annual scientific sessions of the American Heart Association, Sinneave also reported that cardiac death at 1 year was 4% in the pharmaco-invasive group and 4.1% in the those who underwent primary PCI (P=0.93).

During a press briefing, Sinneave said that in the period of 30 days to 1-year, 34 deaths occurred in the study population. Of the patients in the pharmaco-invasive strategy group, there were 20 deaths during that period -- 2.1% of the 944 individuals in the study. Of the 948 patients in the primary PCI strategy, there were 14 deaths (1.5%). Of those, 11 were of a noncardiac nature in the pharmaco-invasive patients and six occurred in those undergoing primary PCI.

He noted that the trial was amended to give half-dose fibrinolysis to patients over age 75 when it appeared that there was a greater risk of stroke in these patients. Sinneave said that after changing the dosing, he was unable to see a difference in outcomes between the two strategies.

"Taken together, these 1-year results indicate that pharmaco-invasive strategy used in STREAM was similar to primary PCI and offers an alternative reperfusion strategy to a substantial proportion of patients worldwide," he said.

The 30-day STREAM results, presented a year ago, showed similar outcomes in ST-elevated myocardial infarction patients who were treated with bolus tenecteplase (TNKase) before transport to a PCI-capable hospital and those patients who were transported without fibrinolysis.

"What this trial shows is that if you can get a patient to a hospital where PCI is performed in a reasonable time, then why go through the extra step of using fibrinolysis because the outcome is the same with primary PCI," study discussant Harold Dauerman, MD, of the University of Vermont in Burlington, told MedPage Today. The cost and the risk of adding another drug which may cause serious bleeding episodes is negated, he suggested.

"This trial may warrant to physicians to adopt half the dose of fibrinolysis for elderly patients in pharmaco-invasive strategies," Dauerman said. He said the lower dose did not appear to cause any further adverse events in the elderly patients.

"In the U.S. most patients can be treated with primary PCI within the windows of this clinical trial. This trial only tried to incorporate patients where there was a 60 minute delay to primary PCI anticipated. So there is a delay factor, but even in that delay factor most patients are going to be treated within a window of time consistent with the guidelines, and outcomes are similar to those as if you had given fibrinolysis first.

"So in areas such as ours where 80% to 90% are already part of networks where there's PCI [available], these results won't change the practice pattern significantly. In areas where primary PCI is not an option for economic or geographic reasons, this approach gives another option to start pharmaco-invasive therapy early reperfusion. And I am not only thinking about rural areas of American but for countries like India and China where use of reperfusion therapy occurs in less than 75% of patients."

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